Bone Marrow Transplant (BMT)
Bone Marrow Transplant (BMT)
1
| Disease Status and/or Stage | Leukemia, Multiple Myeloma and Lymphoma Patients Undergoing Allogeneic Transplantation |
|---|---|
| Protocol Title | A Randomized, Double-blind, Placebo-controlled Trial to Evaluate Palifermin (rHuKGF) in the Reduction of Acute Graft Versus Host Disease in Subjects with Hematologic Malignancies Undergoing Allogeneic Marrow/PBPC Transplantation |
| PI | Tsiporah Shore, MD |
| Contact | June Greenberg, RN 212-746-2651 |
| Key Eligibility | 1. Subjects with hematologic malignancies who are considered eligible for cyclophosphamide/total body irradiation (Cy/TBI) +/- etoposide (VP- 16); TBI/VP-16; melphalan (Mel)/TBI; busulfan (Bu)/Cy; or Bu/Mel conditioning therapy with allogeneic stem cell support. 2. Subjects with a 6/6 HLA-matched family member or unrelated donor who would provide donor marrow/peripheral progenitor stem cells. |
| Treatment Overview |
Placebo or palifermin will be administered daily for 3 consecutive days prior to the start of the patient’s conditioning regimen, and a fourth dose will be administered approximately 96 hours after the third dose, to coincide with the allogeneic transplant. Subjects will have follow-up examinations at 6 months and years 1, 2, 3, 4, and 5 post-transplantation. |
2
| Disease Status and/or Stage | Not Applicable |
|---|---|
| Protocol Title | Open-label trial of peripheral blood progenitor cell (PBPC) mobilization by Filgrastim in normal donors |
| PI | Tsiporah Shore, MD |
| Contact | June Greenberg, RN 212-746-2651 |
| Key Eligibility | Subjects must be eligible to be peripheral blood progenitor cell (PBPC) donors for allogeneic transplantation (related or unrelated). |
| Treatment Overview | Subjects will undergo splenic assessments at baseline and the day of first leukapheresis. Subjects will be followed for adverse events through 7 days after the last leukapheresis. |
3
| Disease Status and/or Stage | Chronic GvHD |
|---|---|
| Protocol Title | CALGB 100101: A Phase II Trial of Pentostatin for the Treatment of Patients with Refractory Chronic Graft-Versus-Host Disease |
| PI | Tsiporah Shore, MD |
| Contact | June Greenberg, RN 212-746-2651 |
| Key Eligibility |
Histological documentation of chronic GvHD following allogeneic hematopoietic stem cell transplantation (HCT) Failed treatment with or experienced progression after prior corticosteroids for extensive chrnoic GvHD |
| Treatment Overview |
Pentostatin IV over 20-30 minutes every 2 weeks Patients should receive an effective antiemetic 30 minutes prior to each dose of pentostatin Patients should receive prophylactic therapy |
4
| Disease Status and/or Stage | Autologous Hematopoietic Stem Cell Transplant for Relapsed or Refractory Diffuse Large B-Cell Non-Hodgkin's Lymphoma |
|---|---|
| Protocol Title | BMT CTN 0401: Phase III Rituxan/BEAM vs. Bexxar/BEAM with Autologous Hematopoietic Stem Cell Tranplantation (ASCT) for Persistent or Relapsed Chemotherapy Sensitive Diffuse Large B-Cell Non-Hodgkin's Lymphoma |
| PI | Tsiporah Shore, MD |
| Contact | June Greenberg, RN 212-746-2651 |
| Key Eligibility | Patients have persistent or recurrent diffuse large B-Cell lymphoma. Patients must have received 1-3 prior treatment regimens, including an induction chemotherapy and greater than or equal to 2 slavage regimens. |
| Treatment Overview | Eligible patients will be randomized to receive either: 1) Rituxan plus BEAM or 2) Bexxarr/BEAM with the dosimetric dose of 5 mCi Bexxar on Day -19 and the therapeutic dose calculated to administer 75 cGy total body dose (TBD) on Day -12. Patients will then receive BCNU 300 mg/m2 Day -6, Etoposide 100 mg/m2 BID Days -5 to -2, Cytarabine 100 mg/m2 BID Days -5 to -2, and Melphalan 140 mg/m2 Day -1 followed by ASCT. |
5
| Disease Status and/or Stage | Bone Marrow Transplant |
|---|---|
| Protocol Title | Training Patients for HSCT - A Novel Coping Skills Intervention |
| PI | Michael Schuster, MD |
| Contact | June Greenberg, RN 212-746-2651 |
| Key Eligibility | Patients will be receiving a Hematopoietic Stem Cell Tranplant for treatment of hematological malignancies and related diseases. They must have a spouse or partner who has cohabitated with the patient three months prior to tranplant and will serve as a primary caretaker throughout the transplant process. |
| Treatment Overview |
Patients are randomized to address the needs of a bone marrow transplant recipient (and partner/spouse) by examining the benefit of a three-session, couple-focused, telephone-delivered Coping Skills Training (CST) Intervention designed to teach patients and their partners effective coping strategies to manage uncertainty and stressful situations that may arise during the transplant process together. Couples will be randomized to one of two treatment conditions: 1) couple-focused CST plus usual care (Usual care - defined as the care a patient would receive if not enrolled in the study) or 2) Usual Care only. This intervention aims to equip patients & partner/spouse with effective coping skills they can employ individually or together to manage the stressors of transplant and mitigate the likelihood of psychosocial distress. |
| Last updated: July 22, 2008 |  |
